Androgel topical gel is indicated as hormone replacement therapy for testosterone in men with hypogonadism, if its deficiency is confirmed by the clinical course and laboratory tests.
Active ingredient: testosterone;
1 g of gel contains testosterone 0.01 g;
Excipients: isopropyl myristate, ethanol 96%, carbomer 980, sodium hydroxide 0.1 N, purified water.
Diagnosed or suspected prostate or breast cancer.
Hypersensitivity to testosterone or any other component of the preparation.
For external use (on the skin).
Adult men and elderly men. The recommended dose is 5 g of gel (50 mg of testosterone), which is applied once a day, preferably at the same time in the morning. The daily dose can be adjusted by the doctor individually for each patient, depending on the clinical effect and the results of laboratory control, but should not exceed 10 g of gel per day. The dose should be increased in steps of 2.5 g of gel.
The gel should be applied by patients themselves to clean, dry, healthy skin on the shoulders, arms or abdomen.
After opening the sachet, the entire contents should be squeezed out and immediately applied to the skin. The gel should not be rubbed into the skin, but smeared with a thin layer on the skin with light movements. Let dry for at least 3-5 minutes before dressing. After applying the gel, wash your hands with soap and water.
The gel should not be applied to the genitals (penis and testicles), as high concentrations of alcohol may cause local irritation.
pregnant
Androgel is intended only for the treatment of men.
Children
Androgel is not indicated for use in children and has not been clinically evaluated in male patients under 18 years of age.
Drivers
Studies of the effect on the ability to drive vehicles or work with other mechanisms have not been conducted.
Only one case of acute testosterone overdose after injection has been reported in the literature. This concerned a violation of cerebral blood flow in a patient with a high concentration of testosterone in the blood plasma - 114 ng / ml (395 nmol / l). It is unlikely that such a high level of testosterone can be achieved with transdermal application.
Most often, when using the recommended dose (5 g of gel per day), skin reactions (10%) may occur: skin irritation at the site of application of the gel, erythema, acne, dry skin.
With simultaneous use with oral anticoagulants, a change in anticoagulant activity is possible (an enhanced effect of an oral anticoagulant is possible due to modification of the coagulation factor of hepatic synthesis and competitive inhibition of binding to plasma proteins).
Careful monitoring of prothrombin time and determination of International Normalized Ratios (INR) is recommended. Patients receiving oral anticoagulants need careful monitoring, especially at the beginning of the use of androgens or after their withdrawal.
Co-administration of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may increase the risk of edema. Therefore, these preparations in combination should be used with caution, especially in patients with heart, kidney or liver disease.
Store at a temperature not exceeding 25°C.
Keep out of the reach of children.
Shelf life - 3 years.
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